FDAFDA · Food and drugs·Recall number Z-0508-2020
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Published December 11, 2019 · Recall initiated: October 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)
- Lot
- Product Number 8637-20 Serial Numbers: NGP000003H NGP000008H NGP000009H NGP000011H NGP000013H NGP000014H NGP000017H NGP000018H NGP000019H NGP000020H NGP000023H NGP000024H NGP000026H NGP000027H NGP000029H NGP000031H NGP000032H NGP000033H NGP000034H NGP000035H NGP000036H NGP000037H NGP000038H NGP000039H NGP000040H NGP000046H NGP000048H NGP000071H NGP000076H NGP000086H NGP000106H NGP000107H NGP000111H NGP000119H NGP000128H NGP000138H NGP000142H NGP000143H NGP000145H NGP000150H NGP000159H NGP000160H NGP000163H NGP000176H NGP000178H NGP000184H NGP000197H NGP000198H NGP000199H NGP000204H NGP000242H NGP000245H NGP000249H NGP000251H NGP000252H NGP000253H NGP000254H NGP000255H NGP000256H NGP000257H NGP000258H NGP000261H NGP000269H NGP000270H NGP000274H NGP000276H NGP000278H NGP000281H NGP000282H NGP000290H NGP000293H NGP000295H NGP000296H NGP000299H NGP000300H NGP000303H NGP000304H NGP000308H NGP000311H NGP000313H NGP000317H NGP000324H NGP000325H NGP000329H NGP000330H NGP000334H NGP000337H NGP000339H NGP000340H NGP000343H NGP000351H NGP000352H NGP000353H NGP000360H NGP000362H NGP000363H NGP000366H NGP000367H NGP000374H NGP000375H NGP000376H NGP000377H NGP000382H NGP000386H NGP000390H NGP000397H NGP000399H NGP000419H NGP000427H NGP000445H NGP000456H NGP000468H NGP000469H NGP000477H NGP000482H NGP000487H NGP000489H NGP000491H NGP000494H NGP000495H NGP000498H NGP000500H NGP000503H NGP000507H NGP000512H NGP000514H NGP000516H NGP000517H NGP000518H NGP000519H NGP000524H NGP000527H NGP000529H NGP000531H NGP000534H NGP000536H NGP000539H NGP000545H NGP000546H NGP000547H NGP000548H NGP000550H NGP000552H NGP000560H NGP000562H NGP000563H NGP000564H NGP000565H NGP000568H NGP000579H NGP000580H NGP000585H NGP000601H NGP000602H NGP000603H NGP000604H NGP000605H NGP000606H NGP000607H NGP000609H NGP000610H NGP000611H NGP000612H NGP000613H NGP000614H NGP000615H NGP000616H NGP000618H NGP000619H NGP000621H NGP000622H NGP000623H NGP000624H NGP000625H NGP000626H NGP000627H NGP000628H NGP000630H NGP000632H NGP000633H NGP000634H NGP000635H NGP000636H NGP000639H NGP000640H NGP000643H NGP000645H NGP000649H NGP000654H NGP000656H NGP000660H NGP000661H NGP000664H NGP000669H NGP000674H NGP000688H NGP000690H NGP000693H NGP000700H NGP000701H NGP000708H NGP000709H NGP000711H NGP000715H NGP000717H NGP000719H NGP000720H NGP000723H NGP000724H NGP000727H NGP000728H NGP000731H NGP000732H NGP000733H NGP000734H NGP000735H NGP000739H NGP000745H NGP000749H NGP000751H NGP000752H NGP000754H NGP000756H NGP000758H NGP000759H NGP000760H NGP000763H NGP000766H NGP000767H NGP000768H NGP000772H NGP000774H NGP000775H NGP000776H NGP000777H NGP000778H NGP000779H NGP000780H NGP000787H NGP000806H NGP000815H NGP000828H NGP000834H NGP000837H NGP000839H NGP000849H NGP000853H NGP000854H NGP000863H NGP000872H NGP000873H NGP000881H NGP000883H NGP000885H NGP000886H NGP000888H NGP000889H NGP000890H NGP000896H NGP000897H NGP000898H NGP000903H NGP000905H NGP000906H NGP000908H NGP000909H NGP000910H NGP000911H NGP000926H NGP000932H NGP000935H NGP000939H NGP000945H NGP000948H NGP000949H NGP000953H NGP000959H NGP000961H NGP000963H NGP000974H NGP000975H NGP000976H NGP000977H NGP000979H NGP000981H NGP000988H NGP000991H NGP000997H NGP001001H NGP001019H NGP001047H NGP001051H NGP001053H NGP001054H NGP001056H NGP001066H NGP001067H NGP001068H NGP001069H NGP001070H NGP001071H NGP001072H NGP001073H NGP001074H NGP001075H NGP001076H NGP001077H NGP001081H NGP001084H NGP001086H NGP001109H NGP001129H NGP001171H NGP001172H NGP001173H NGP001178H NGP001182H NGP001183H NGP001184H NGP001192H NGP001206H NGP001226H NGP001232H NGP001233H NGP001234H NGP001236H NGP001238H NGP001239H NGP001241H NGP001242H
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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